510(k) K912371 ยท LKT Respiratory Syncytial Virus, Antigen, Antibody, Ifa
BIOMERIEUX RSV DIRECT IF KIT
| Applicant | Vitek Systems, Inc., Hazelwood MI, US |
| Decision | Substantially Equivalent, Sep 23, 1991 |
| Received | May 29, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912371
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.